ZINC OXIDE OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]

ZINC OXIDE OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]
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NDC 50382-051-01, 50382-051-02, 50382-051-03
Set ID 1deec882-5c29-44f8-8a74-4ec5bed2eadc
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Priva Te Limited
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Section Text

    Active Ingredient                            Purpose

    Zinc Oxide (200mg in each gram)   Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash.
    • Dries the oozing and weeping of;
    • poison ivy
    • poison oak
    • poison sumac
  • Warnings:

    For External Use Only

  • When using this product:

    • Do not get in eyes.
  • Stop use and ask a doctor if:

    • conditions worsens
    • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician.
    • over large areas of the body
    • if you are allergic to any of these ingredients
  • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    For diaper rash:

    • change wet and soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

    For poison ivy, poison oak, poison sumac:

    • apply liberally as often as needed
  • Inactive Ingredients

    Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

  • Principal Display

    Galzinc.jpg

    Galentic zinc oxide

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-051-0372 in 1 CASE
    128.34 g in 1 TUBE
    2NDC:50382-051-0172 in 1 CASE
    256.68 g in 1 TUBE
    3NDC:50382-051-0212 in 1 CASE
    3425.1 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/19/2013
    Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-051)

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